The field of this invention relates to using an oxygen concentrator to create a portable supply of supplementary oxygen for ambulatory respiratory patients so that they can lead normal and productive livesxe2x80x94as the typical primary oxygen sources are too bulky to carry or require excessive power to operate.
There is a burgeoning need for home and ambulatory oxygen. Supplemental oxygen is necessary for patients suffering from lung disorders; for example, pulmonary fibrosis, sarcoidosis, or occupational lung disease. For such patients, oxygen therapy is an increasingly beneficial, life-giving development. While not a cure for lung disease, supplemental oxygen increases blood oxygenation, which reverses hypoxemia. This therapy prevents long-term effects of oxygen deficiency on organ systemsxe2x80x94in particular, the heart, brain and kidneys. Oxygen treatment is also prescribed for Chronic Obstructive Pulmonary Disease (COPD), which afflicts about 25 million people in the U.S., and for other ailments that weaken the respiratory system, such as heart disease and AIDS. Supplemental oxygen therapy is also prescribed for asthma and emphysema.
The normal prescription for COPD patients requires supplemental oxygen flow via nasal cannula or mask twenty four hours per day. The average patient prescription is two liters per minute of high concentration oxygen to increase the oxygen level of the total air inspired by the patient from the normal 21% to about 40%. While the average oxygen flow requirement is two liters per minute, the average oxygen concentrator has a capacity of four to six liters of oxygen per minute. This extra capacity is occasionally necessary for certain patients who have developed more severe problems but they are not generally able to leave the home (as ambulatory patients) and do not require a portable oxygen supply.
There are currently three modalities for supplemental medical oxygen: high pressure gas cylinders, cryogenic liquid in vacuum insulated containers or thermos bottles commonly called xe2x80x9cdewars,xe2x80x9d and oxygen concentrators. Some patients require in-home oxygen only while others require in-home as well as ambulatory oxygen depending on their prescription. All three modalities are used for in-home use, although oxygen concentrators are preferred because they do not require dewar refilling or exchange of empty cylinders with full ones.
Only small high pressure gas bottles and small liquid dewars are portable enough to be used for ambulatory needs (outside the home). Either modality may be used for both in-home and ambulatory use or may be combined with an oxygen concentrator which would provide in-home use.
As we describe below, the above-described current methods and apparatus have proven cumbersome and unwieldy and there has been a long-felt need for improved means to supply the demand for portable/ambulatory oxygen.
For people who need to have oxygen but who need to operate away from an oxygen-generating or oxygen-storage source such as a stationary oxygen system (or even a portable system which cannot be easily carried), the two most prescribed options generally available to patients are: (a) to carry with them small cylinders typically in a wheeled stroller; and (b) to carry portable containers typically on a shoulder sling. Both these gaseous oxygen and liquid oxygen options have substantial drawbacks. But from a medical view, both have the ability to increase the productive life of a patient.
The major drawback of the gaseous oxygen option is that the small cylinders of gaseous oxygen can only provide gas for a short duration. Oxygen conserving devices that limit the flow of oxygen to the time of inhalation may be used. However, the conserving devices add to the cost of the service and providers have been reluctant to add it because there often is no health insurance reimbursement. Indeed, the insurance reimbursement for medical oxygen treatment appears to be shrinking.
Another drawback of the gaseous oxygen option is the source of or refill requirement for oxygen once the oxygen has been depleted from the cylinder. These small gas cylinders must be picked up and refilled by the home care provider at a specialized facility. This requires regular visits to a patient""s home by a provider and a substantial investment in small cylinders for the provider because so many are left at the patient""s home and refilling facility. Although it is technically possible to refill these cylinders in the patient""s home using a commercial oxygen concentrator that extracts oxygen from the air, this task would typically require an on-site oxygen compressor to boost the output pressure of the concentrator to a high level in order to fill the cylinders. Additionally, attempting to compress the oxygen in pressurized canisters in the home is dangerous, especially for untrained people. This approach of course presents several safety concerns for in-home use. For example, in order to put enough of this gas in a portable container, it must typically be compressed to high pressure (xcx9c2000 psi). Compressing oxygen from 5 psi (the typical output of an oxygen concentrator) to 2000 psi will produce a large amount of heat. (Enough to raise the temperature 165xc2x0 C. per stage based on three adiabatic compression stages with intercooling.) This heat, combined with the oxygen which becomes more reactive at higher pressures, sets up a potential combustion hazard in the compressor in the patient""s home. Thus, utilizing and storing a high pressure gas system in the patient""s home is dangerous and not a practical solution.
The convenience and safety issues are not the only drawbacks of this compressed oxygen approach. Another drawback is that the compressors or pressure boosters needed are costly because they require special care and materials needed for high pressure oxygen compatibility. For example, a Rix Industries, Benicia, Calif., ⅓ hp unit costs about $10,000 while a Haskel International, Burbank, Calif., air-powered booster costs about $2200 in addition to requiring a compressed air supply to drive it. Litton Industries and others also make oxygen pressure boosters.
Turning now to the liquid oxygen storage option, its main drawback is that it requires a base reservoirxe2x80x94a stationary reservoir base unit about the size of a standard beer kegxe2x80x94which has to be refilled about once a week. The liquid oxygen can then be obtained from a base unit and transferred to portable dewars which can be used by ambulatory patients. Also, with the liquid oxygen option, there is substantial waste, as a certain amount of oxygen is lost during the transfer to the portable containers and from evaporation. It is estimated that 20% of the entire contents of the base cylinder will be lost in the course of two weeks because of losses in transfer and normal evaporation. These units will typically boil dry over a period of 30 to 60 days even if no oxygen is withdrawn.
There are other complications. Typically, supplemental oxygen is supplied to the patient by a home care provider, in exchange for which it receives a fixed monetary payment from insurance companies or Medicare regardless of the modality. Oxygen concentrators for use in the home are preferred and are the least expensive option for the home care provider. For outside the home use however, only small high pressure gas bottles and small liquid dewars are portable enough to be used for ambulatory needs. One of these two modalities may be used for both in-home and ambulatory use or may be combined with an oxygen concentrator which would provide in-home use. In either case, the home care provider must make costly weekly or biweekly trips to the patient""s home to replenish the oxygen. One of the objects of this invention is to eliminate these costly xe2x80x9cmilk runs.xe2x80x9d
Portable oxygen concentrators are commercially available for providing patients with gaseous oxygen. These devices are xe2x80x9cportablexe2x80x9d solely in the sense that they can be carried to another point of use such as in an automobile or in an airplane. At present, there are no home oxygen concentrators commercially available that can provide liquid oxygen. One type of medical oxygen concentrator takes in air and passes it through a molecular sieve bed, operating on a pressure swing adsorption cycle, which strips most of the nitrogen out, producing a stream of xcx9c90% oxygen, for example, as shown in U.S. Pat. Nos. 4,826,510 and 4,971,609 (which are incorporated herein by reference). While, as set out in the Information Disclosure Statement, complex oxygen liquefaction systems have been disclosed for use by the military in jet aircraft, and while large-scale commercial plants have been disclosed, this technology has not yet found its way into the home to help individual patients and to benefit the general public. A truly portable oxygen concentrator has not yet been perfected and this event is unlikely, at least in the near future, because the power requirements are too large to be provided by a lightweight battery pack.
Since liquid oxygen requires periodic delivery and home oxygen concentrators are not commercially available that would create liquid oxygen, there has existed a long-felt need for a device or method having the capability to concentrate oxygen from the air, liquefy it, and transfer it into portable dewars in a home environment, and for a home oxygen concentrator unit which allows excess flow capacity from the concentrator to be stored by either compression or liquefaction for later use.
The present invention presents a much safer and less expensive way of providing portable oxygen for patients who do not want to be tied to a stationary machine or restricted by present oxygen technology. In one preferred embodiment, the present invention splits off some of the excess capacity gas flow from a PSA (pressure swing adsorption) or membrane gas concentrator which has a relatively stable base load. This small portion of the excess flow capacity, about one liter per minute (xcx9c1 LPM) is stored via liquefaction. The stored gas can then be used as a portable supply away from the location of the gas concentrator. The daily six hour range capacity for a two liter per minute patient can be accumulated by liquefying a one liter per minute gas flow for less than 24 hours. Therefore, the entire daily requirement for mobility can be produced every day if needed.
A summary of one of the many representative embodiments of the present invention is disclosed including a home liquid oxygen ambulatory system for supplying a portable supply of oxygen, where a portion of the gaseous oxygen output obtained from an oxygen concentrator is condensed into liquid oxygen, comprising: (a) an oxygen concentrator which separates oxygen gas from the ambient air; (b) an outlet flow line to transfer flow of oxygen gas from said oxygen concentrator for patient use; (c) a valve placed in the outlet flow line for splitting off a portion of the oxygen gas flow generated by the oxygen generator; (d) a generally vertically oriented, gravity assisted, condenser for receiving and liquefying the split off portion of the oxygen gas flow; (e) a cryocooler associated with said condenser; (f) a first storage dewar in fluid communication with said condenser for storing the oxygen liquefied by the condenser, the first storage dewar having an outlet selectively engageable to and in fluid communication with at least one second smaller dewar and a fluid path for supplying liquid oxygen from the first dewar to the second dewar; (g) a heater for heating said first storage dewar; (h) a controller for monitoring (i) oxygen concentration of the oxygen gas flowing from said concentrator, and (j) the amount of liquid oxygen in said first dewar, and for controlling the parameters of liquid oxygen generation and transfer from said first storage dewar.
Another representative embodiment is the feature where the flow rate into the condenser is chosen to exceed the capacity of the condenser. In particular, only 20 to 90% of the incoming flow into the condenser is condensed to minimize the liquefaction of argon, nitrogen and trace gases, and to purge the system.
Additionally, the controller may control condenser parameters so that the condenser temperature varies in the range from approximately 69.2 to 109.7 K, the condenser pressure varies from approximately 5 to 65 psia, and the concentrations of gas into the condenser varies with the oxygen range being 80 to 100%, the nitrogen range being 0 to 20%, and the argon range being 0 to 7%.
A unique condenser design is also disclosed where the condenser is in thermal contact with a cryocooler for use in liquefying oxygen and comprises: (a) an inlet conduit for receiving oxygen; (b) an outer member; (c) an inner member; (d) a passage defined by said outer and inner members; (e) said inner member having radial slots to passages; (f) means for circulating said oxygen in said condenser.
Also disclosed is a representative method for controlling a home ambulatory liquid oxygen system comprised of an oxygen concentrator, a controller having a microprocessor, a condenser, a cryocooler and a storage dewar, where all or only a portion of the oxygen flow is utilized for liquefaction, comprising: (a) providing the microprocessor with a database and control functions; (b) sensing the parameters relating to the concentration and supply of gaseous oxygen, the level of liquid oxygen in the dewar, and the pressure of the condenser; (c) providing the microprocessor with these sensed parameters and having the microprocessor calculate optimal conditions; (d) controlling servomechanisms to regulate the system so that optimal conditions are realized as a function of said calculations.
The feature is also described wherein the liquid dewar will be periodically boiled dry to eliminate any small amounts of water and hydrocarbons that may pass through the gas concentrator.
The above-summarized apparatus and methods, more specifically set out in the claims, fill long-felt needs without posing any new safety issues to the patient in that, for example, there are no potentially dangerous canisters of high pressure compressed oxygen. The end result is that patients can ultimately use equipment with which they are familiar. For example, patients on liquid oxygen currently perform liquid transfers from large (30-50 liquid liter) dewars to small (0.5-1.2 liquid literxe2x80x94corresponding to six hours of support) portable dewars. The present invention will provide a means of supplying ambulatory oxygen for a lower life cycle cost than the conventional method. Unlike industrial or military use liquefiers, which can take up whole rooms, the claimed oxygen liquefier (not including the oxygen concentrator) weighs less than 60 pounds and takes up less than six cubic feet of volume. There are currently about 700,000 patients in the United States using ambulatory oxygen with an average yearly cost of about $1,960 per patient. The estimated annual cost of oxygen per patient with the present invention is about $540.